Advances in medical treatment and improved procedures constantly increase the need for improved valves and connectors. The demands relating to variety of types, quality, needle safety, microbial ingress prevention and leak prevention are constantly growing. Additionally, advances in sampling or dose dispensing technologies, automated and manual, aseptic or non aseptic applications, call for new safe concealing solutions for the sampling needle. One extremely demanding application exists in the field where medical and pharmacological personnel that are involved in the preparation and administration of hazardous drugs suffer the risk of being exposed to drugs and to their vapors, which may escape to the surroundings. As referred to herein, a “hazardous drug” is any injectable material the contact with which, or with the vapors of which, may constitute a health hazard. Illustrative and non-limitative examples of such drugs include, inter alia, cytotoxins, antiviral drugs, chemotherapy drugs, antibiotics, and radiopharmaceuticals, such as herceptin, cisplatinum, fluorouracil, leucovorin, paclitaxel, etoposide, cyclophosphamideand neosar, or a combination thereof, in a liquid, solid, or gaseous state.
Hazardous drugs in liquid or powder form are contained within vials, and are typically prepared in a separate room by pharmacists provided with protective clothing, a mouth mask, and a laminar flow safety cabinet. A syringe provided with a cannula, i.e. a hollow needle, is used for transferring the drug from a vial. After being prepared, the hazardous drug is added to a solution contained in a bag which is intended for parenteral administration, such as a saline solution intended for intravenous administration.
Since hazardous drugs are toxic, direct bodily contact thereto, or exposure to even micro-quantities of the drug vapors, considerably increases the risk of developing health fatalities such as skin cancer, leukemia, liver damage, malformation, miscarriage and premature birth. Such exposure can take place when a drug containing receptacle, such as a vial, bottle, syringe, and intravenous bag, is subjected to overpressure, resulting in the leakage of fluid or air contaminated by the hazardous drug to the surroundings. Exposure to a hazardous drug also results from a drug solution remaining on a needle tip, on a vial or intravenous bag seal, or by the accidental puncturing of the skin by the needle tip. Additionally, through the same routes of exposure, microbial contaminants from the environment can be transferred into the drug and fluids; thus eliminating the sterility with possibly fatal consequences.
In copending PCT Patent Application No. PCT/IL2014/050319 there is described a needle valve comprised of:                a. at least one hollow needle comprised of a smooth surfaced hollow shaft and a port located in the side of the shaft at the distal end close, to the tip of the needle, the port adapted to allow fluid communication between the interior and the exterior of the needle; and        b. a seat made of rigid material, the seat comprising at least one bore adapted to accommodate one of the at least one needles through the seat;wherein:        i. said needle can be pushed back and forth through said bore; and the outer diameter of said needle and the inner diameter of at least part of said bore are so closely matched that the presence of the shaft of said needle in said bore blocks the passage of fluid through said part of said bore.        
The connector of PCT/IL2014/050319 is characterized in that the single membrane seal actuator comprises a rigid plastic needle valve seat located proximally of the membrane, the needle valve seat comprising a bore, wherein the bore is adapted to each allow the needle to be pushed back and forth through it and at least a portion of each of the bore is adapted such that fluid cannot pass through the portion when the needle is at least partially located in the bore;
wherein, the connector is configured to allow a head portion of the second fluid transfer component to enter the interior of the connector section and to allow the single membrane actuator to be pushed proximally when the membrane at its distal end is contacted by a membrane located in the head portion of the second fluid transfer component; whereupon further pushing of the membranes together causes the distal end of the needle to exit the distal end of the bore and to penetrate the membrane in the single membrane actuator and to penetrate the membrane in the head portion, thereby establishing a fluid channel via the needle between the connection port and the interior of the second fluid transfer component.
However, it has been found that, while the device described in PCT/IL2014/050319 greatly improves over the prior art, the manufacturing process and the constant quality of manufactured devices can be further significantly improved if the bore provided in the needle valve seat, which is adapted to each allow the needle to be pushed back and forth through it, is made of resilient material. This allows for greater flexibility in machining and overcomes the problems due to hole diameter variability that may result during production, which lead to less constant product parameters.
Another deficiency of the prior art is the high friction between needle to bore that requires much force to move the needle or to move the connector during connection or disconnection. This is problematic for the user.
It is therefore a purpose of the present invention to provide needle valves that overcome the above described problems.
Further purposes and advantages of this invention will appear as the description proceeds.